Micro Therapeutics recalls two Axium Detachable Coil System models due to incorrect size and configuration labeling, which may lead to improper use. Affected units include QC-4-12-HELIX and QC-10-30-3D with specific lot numbers.
Due to incorrect size and configuration labeling of the detachable coil system.
Micro Therapeutics is recalling two specific models of detachable coil systems because their size and configuration labels are incorrect. This could lead to improper use if the coils are not properly matched to the intended medical device.
The incorrect labeling means the coil system might not fit correctly with the intended medical device. This could lead to improper use during procedures, potentially causing complications if the coils are not properly matched.
Patients using these specific medical coil systems for procedures are likely affected. Those with the incorrect labeling may face improper use if the coils are not properly matched to the intended device.
Check for product numbers QC-4-12-HELIX or QC-10-30-3D. The lot numbers B240079 and B240084 are also associated with these models.
Look for the product number and lot number on the device to confirm if it is affected.
The recalled models are Axium Detachable Coil System REF QC-4-12-HELIX and QC-10-30-3D.
Check for product numbers QC-4-12-HELIX or QC-10-30-3D with lot numbers B240079 or B240084.
The recall does not specify a remedy, so contact Micro Therapeutics directly for guidance.
We’ve drafted a message you can send Micro Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-1261-2022 — Micro Therapeutics Micro Therapeutics Hello, I own a Micro Therapeutics that is covered by recall Z-1261-2022 from Micro Therapeutics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
